Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

714

Participants

Timeline

Start Date

December 17, 2018

Primary Completion Date

July 25, 2024

Study Completion Date

September 10, 2026

Conditions
Head and Neck Neoplasms
Interventions
BIOLOGICAL

Pembrolizumab 200 mg

200 mg administered IV infusion on Day 1 of each 21-day cycle

RADIATION

Radiotherapy 60 Gray

Low risk participants administered 2 Gray in 30 fractions. Administered using intensity modulated radiation therapy.

RADIATION

Radiotherapy 66 Gray

High risk participants administered 2 Gray in 33 fractions. Administered using intensity modulated radiation therapy.

RADIATION

Radiotherapy 70 Gray

Participants with gross residual disease administered 2 Gray in 35 fractions. Administered using intensity modulated radiation therapy.

DRUG

Cisplatin 100 mg/m^2

100 mg/m\^2 administered by IV infusion on Day 1 of each 21-day cycle

Trial Locations (192)

704

National Cheng Kung University Hospital ( Site 1302), Tainan City

833

Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1303), Kaohsiung City

1012

IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0016), Buenos Aires

1062

Eszak-Pesti Centrumkorhaz-Honvedkorhaz ( Site 0453), Budapest

1090

Medizinische Universität Wien ( Site 1903), Vienna

1122

Orszagos Onkologiai Intezet ( Site 0454), Budapest

1211

Hopitaux Universitaires de Geneve HUG ( Site 1920), Geneva

2000

Fundacion Estudios Clinicos-Oncology ( Site 0017), Rosario

2145

The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 0051), Westmead

4010

Ordensklinikum Linz Gmbh - Barmherzige Schwestern ( Site 1901), Linz

4029

Royal Brisbane and Women s Hospital ( Site 0050), Herston

5000

Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0450), Szolnok

5020

Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 1900), Salzburg

6500

Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1921), Bellinzona

7100

Hopital de Jolimont ( Site 0103), Haine-Saint-Paul

7621

Pecsi Tudomanyegyetem Onkoterapias Intezet ( Site 0452), Pécs

8036

Landeskrankenhaus - Universitatsklinikum Graz ( Site 1902), Graz

8091

Universitaetsspital Zurich ( Site 1923), Zuerich

9000

UZ Gent ( Site 0101), Ghent

9100

AZ Nikolaas ( Site 0104), Sint-Niklaas

10002

National Taiwan University Hospital ( Site 1300), Taipei

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 2014), New York

10065

Memorial Sloan Kettering Cancer Center ( Site 1857), New York

Weill Cornell Medical College ( Site 2050), New York

10075

Northwell Health Cancer Institute ( Site 2030), New York

10408

National Cancer Center ( Site 0702), Goyang-si

10467

Montefiore Einstein Center ( Site 2028), The Bronx

10604

Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 2041), Harrison

11042

Monter Cancer Center ( Site 2060), Lake Success

11553

Memorial Sloan Kettering Cancer Center - Nassau ( Site 2040), Uniondale

11725

Memorial Sloan-Kettering Cancer Center at Commack ( Site 2038), Commack

11794

Stony Brook University ( Site 2063), Stony Brook

12203

Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 0414), Berlin

13385

Hopital de la Timone ( Site 0356), Marseille

13620

Seoul National University Bundang Hospital ( Site 0703), Seongnam-si

14215

Erie County Medical Center ( Site 2047), Buffalo

15212

Allegheny General Hospital ( Site 1833), Pittsburgh

15706

Hospital Clinico Universitario de Santiago ( Site 1207), Santiago de Compostela

16247

The Catholic University of Korea St. Vincent s Hospital ( Site 0704), Gyeonggi-do

18015

St. Luke's University Health Network ( Site 1801), Bethlehem

19107

Sidney Kimmel Cancer Center - Jefferson Health ( Site 2059), Philadelphia

20010

MedStar Washington Hospital Center ( Site 2062), Washington D.C.

20037

George Washington University Medical Faculty Associates ( Site 2035), Washington D.C.

20246

Universitaetsklinikum Hamburg Eppendorf ( Site 0407), Hamburg

21201

University of Maryland ( Site 2031), Baltimore

22031

Inova Schar Cancer Institute ( Site 2026), Fairfax

22908

UVA Health System - Emily Couric Cancer Center ( Site 1826), Charlottesville

23538

Universitätsklinikum Schleswig-Holstein ( Site 0411), Lübeck

25006

PP PPC Acinus Medical and Diagnostic Centre ( Site 1704), Kropyvnytskyi

25011

Ukrainian Center of Tomotherapy ( Site 1708), Kropyvnitskiy

27357

Wake Forest Compenhensive Cancer Center ( Site 2029), Winston-Salem

28046

Hospital Universitario La Paz ( Site 1201), Madrid

28204

Levine Cancer Institute ( Site 2003), Charlotte

31059

Institut Claudius Regaud IUCT Oncopole ( Site 0355), Toulouse

32608

University of Florida ( Site 1832), Gainesville

32804

AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 2054), Orlando

32806

Orlando Health Cancer Institute ( Site 2061), Orlando

33136

University of Miami, Sylvester Comprehensive Cancer Center ( Site 2008), Miami

34125

Klinikum Kassel GmbH ( Site 0404), Kassel

37232

Henry Joyce Cancer Clinic ( Site 1827), Nashville

40536

University of Kentucky Chandler Medical Center-Medical Oncology ( Site 2069), Lexington

40705

Taichung Veterans General Hospital ( Site 1301), Taichung

41013

Hospital Universitario Virgen del Rocio ( Site 1206), Seville

43210

The Ohio State University ( Site 2012), Columbus

44101

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0901), Gliwice

44106

University Hospitals ( Site 2032), Cleveland

48201

Karmanos Cancer Institute ( Site 1870), Detroit

48202

Henry Ford Health System ( Site 1803), Detroit

49005

Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov ( Site 1709), Dnipropetrovsk

49055

Clinical oncology dispensary of Dnipro ( Site 1706), Dnipro

49102

Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1705), Dnipro

50937

Universitaetsklinikum Koeln ( Site 0413), Cologne

55435

Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 2016), Edina

57104

Sanford Cancer Center Oncology Clinic ( Site 1859), Sioux Falls

57105

Avera Cancer Institute- Research ( Site 2070), Sioux Falls

58122

Sanford Health Roger Maris Cancer Center ( Site 2034), Fargo

58128

Chonnam National University Hwasun Hospital ( Site 0705), Hwasun Gun

59102

St. Vincent Healthcare Frontier Cancer Center ( Site 1818), Billings

60153

Loyola University Medical Center [Maywood, IL] ( Site 1817), Maywood

60201

NorthShore University HealthSystem ( Site 1812), Evanston

60590

Universitaetsklinikum Frankfurt ( Site 0403), Frankfurt am Main

60607

Rush University Medical Center ( Site 1823), Chicago

63110

Washington University School of Medicine ( Site 1800), St Louis

65212

University of Missouri Hospital-Otolaryngology - Head and Neck Surgery ( Site 2058), Columbia

65804

Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 1897), Springfield

66205

University of Kansas Cancer Center ( Site 2004), Westwood

70121

Ochsner Cancer Institute ( Site 2045), New Orleans

72076

Universitaetsklinikum Tuebingen - Medizinische Klinik ( Site 0401), Tübingen

75015

Hopital Europeen Georges Pompidou ( Site 0358), Paris

75248

Institut Curie ( Site 0350), Paris

75390

UT Southwestern Medical Center ( Site 1841), Dallas

78229

USA Clinical Trials ( Site 2068), San Antonio

80045

University of Colorado Cancer Center ( Site 1838), Aurora

81675

Klinikum rechts der Isar der Technischen Universitaet ( Site 0409), Munich

Klinikum rechts der Isar der Technischen Universität München-HNO Klinik ( Site 0405), München

83706

Saint Alphonsus Regional Medical Center ( Site 2021), Boise

83854

Beacon Cancer Care ( Site 2052), Post Falls

84918

Institut Sainte Catherine ( Site 0352), Avignon

89075

Universitaetsklinikum Ulm ( Site 0402), Ulm

90033

University of Southern California Norris Comprehensive Cancer Center ( Site 1850), Los Angeles

91054

Universitaetsklinikum Erlangen-Strahlenklinik ( Site 0412), Erlangen

92688

Hoag Memoriall Hospital Presbyterian ( Site 2056), Newport Beach

94800

Institut Gustave Roussy ( Site 0353), Villejuif

95403

St. Joseph Heritage Healthcare ( Site 1806), Santa Rosa

95817

UC Davis Health System ( Site 1864), Sacramento

97220

Providence Portland Medical Center ( Site 1843), Portland

97227

Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 2022), Portland

97239

Oregon Health Science University ( Site 1871), Portland

98109

Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 1865), Seattle

110221

Centro de Investigacion Clinica del Country ( Site 0304), Bogotá

115522

N.N. Blokhin NMRCO ( Site 1005), Moscow

150054

Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1001), Yaroslavl

420029

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1000), Kazan'

661002

Oncologos del Occidente S.A. ( Site 0310), Pereira

760042

Centro Medico Imbanaco de Cali S.A ( Site 0300), Santiago de Cali

3109601

Rambam Health Care Campus-Oncology Division ( Site 0550), Haifa

4963211

Rabin Medical Center ( Site 0552), Petah Tikva

5265601

Chaim Sheba Medical Center. ( Site 0553), Ramat Gan

6423906

Sourasky Medical Center ( Site 0551), Tel Aviv

7500921

Fundacion Arturo Lopez Perez FALP ( Site 0251), Santiago

9112001

Hadassah Medical Center. Ein Kerem ( Site 0554), Jerusalem

92093-0698

Moores Cancer Center ( Site 1885), La Jolla

02215

Dana Farber Cancer Center ( Site 1873), Boston

01655

University of Massachusetts Memorial Medical Center ( Site 1875), Worcester

07920

Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 2036), Basking Ridge

07748

Memorial Sloan Kettering Cancer Center- Monmouth ( Site 2039), Middletown

07645

MSKCC-Bergen ( Site 2037), Montvale

08901

Rutgers Cancer Institute of New Jersey ( Site 2071), New Brunswick

07103

Rutgers New Jersey Medical School-department of Hematology oncology ( Site 2053), Newark

87131-0001

The University of New Mexico Comprehensive Cancer Center ( Site 1882), Albuquerque

84112-5550

University of Utah, Huntsman Cancer Institute ( Site 1855), Salt Lake City

05401

University of Vermont Medical Center ( Site 2009), Burlington

B1629AHJ

Hospital Universitario Austral ( Site 0009), Pilar

C1431FWO

Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0019), Buenos Aires

C1280AEB

Hospital Britanico de Buenos Aires ( Site 0012), Ciudad de Buenos Aires

S2000CVB

Sanatorio Britanico ( Site 0013), Rosario

S2000KZE

Instituto de Oncologia de Rosario ( Site 0002), Rosario

S2002KDS

Hospital Provincial del Centenario ( Site 0008), Rosario

C1118AAT

Hospital Aleman Buenos Aires Argentina ( Site 0004), Buenos Aires

C1417DTB

Instituto de Oncología Angel Roffo ( Site 0003), Buenos Aires

J5402DIL

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0010), San Juan

60336-232

Centro Regional Integrado de Oncologia ( Site 0160), Fortaleza

40050-410

Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0155), Salvador

35162-189

Hospital Marcio Cunha-Unidade de Pesquisa Clínica ( Site 0177), Ipatinga

59075-740

Liga Norte Riograndense Contra o Cancer ( Site 0171), Natal

91359-200

Hospital Nossa Senhora da Conceicao ( Site 0165), Porto Alegre

15090-000

Hospital de Base de Sao Jose de Rio Preto ( Site 0153), São José do Rio Preto

20231-050

Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0169), Rio de Janeiro

01246-000

Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0167), São Paulo

01321-001

BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0175), São Paulo

T6G 1Z2

Cross Cancer Institute ( Site 0201), Edmonton

M4N 3M5

Sunnybrook Research Institute ( Site 0211), Toronto

M5G 2M9

Princess Margaret Cancer Centre ( Site 0202), Toronto

H4A 3J1

McGill University Health Centre ( Site 0210), Montreal

J1H 5N4

CIUSSS de l'Estrie-CHUS ( Site 0209), Sherbrooke

080020

Clinica de la Costa S.A.S. ( Site 0307), Barranquilla

06189

Centre Antoine Lacassagne ( Site 0351), Nice

07548

SRH Wald-Klinikum Gera GmbH ( Site 0406), Gera

Dublin 8

St. James s Hospital ( Site 0500), Dublin

464-8681

Aichi Cancer Center Hospital ( Site 0658), Nagoya

277-8577

National Cancer Center Hospital East ( Site 0661), Kashiwa

673-8558

Hyogo Cancer Center ( Site 0656), Akashi

761-0793

Kagawa University Hospital ( Site 0651), Kita-gun

236-0004

Yokohama City University Hospital ( Site 0657), Yokohama

260-8717

Chiba Cancer Center ( Site 0652), Chiba

811-1395

National Hospital Organization Kyushu Cancer Center ( Site 0660), Fukuoka

734-8551

Hiroshima University Hospital ( Site 0655), Hiroshima

104-0045

National Cancer Center Hospital ( Site 0650), Tokyo

113-8519

Tokyo Medical and Dental University Hospital ( Site 0654), Tokyo

160-0023

Tokyo Medical University Hospital ( Site 0659), Tokyo

31-826

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0905), Krakow

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (, Warsaw

81-159

Szpitale Pomorskie Sp. z o.o. ( Site 0935), Gdynia

93-513

Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0920), Lodz

4710-243

Hospital de Braga ( Site 0951), Braga

1649-035

CHLN Hospital Santa Maria ( Site 0952), Lisbon

1998-018

Hospital CUF Descobertas ( Site 0953), Lisbon

4200-072

Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0950), Porto

03722

Severance Hospital, Yonsei University Health System ( Site 0701), Seoul

08916

Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1204), Badalona

08908

ICO L Hospitalet ( Site 1208), L'Hospitalet de Llobregat

08035

Hospital Vall D Hebron ( Site 1200), Barcelona

08720

LISOD. Hospital ( Site 1707), Pliuty

08111

Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 1703), Kapitanivka Village

03022

National Cancer Institute of the MoH of Ukraine ( Site 1702), Kyiv

03115

Kyiv City Clinical Oncology Centre ( Site 1701), Kyiv

CB2 0QQ

Addenbrooke's Hospital ( Site 1610), Cambridge

HU16 5JQ

Castle Hill Hospital ( Site 1601), Cottingham-Hull

SE1 9RT

Guy s & St Thomas NHS Foundation Trust ( Site 1604), London

SW3 6JJ

Royal Marsden Hospital - Fulham Road London ( Site 1609), London

W6 8RF

Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1603), London

S10 2SJ

Weston Park Hospital ( Site 1607), Sheffield

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY